Laser Catheter with an Adjustable Distal Tip for Increasing the Laser Target Zone
A laser catheter having a compliant balloon and a plurality of optical fibers extending from a base to a tip of the catheter for plaque removal is disclosed. The laser catheter may include a distal flush lumen extending to the tip. The compliant balloon may extend along a longitudinal axis of the laser catheter and may be positioned radially outward from an inner lumen. A plurality of optical fibers may be positioned between the inner lumen and an outer compliant material jacket. In another embodiment, the compliant balloon may be positioned eccentrically with respect to the inner lumen. The eccentrically positioned compliant balloon may further facilitate removal of plaque within arteries.
This patent application claims the benefit of U.S. Provisional Patent Application No. 61/041,724, filed Apr. 2, 2008, U.S. Provisional Patent Application No. 61/056,650, filed May 28, 2008, and U.S. Provisional Patent Application No. 61/056,672, filed May 28, 2008.
FIELD OF THE INVENTIONThis invention is directed generally to catheters, and more particularly to catheters that incorporate lasers for plaque removal.
BACKGROUNDSome conventional catheters include lasers that are intended to ablate plaque in narrowed vessels in the human body, thus re-establishing normal blood flow. These catheters are typically sized to fit within blood vessels in the human body and remove plaque by striking the plaque with laser beams emitted by the lasers. One such catheter is the Turbo Elite laser catheter by Spectranetics of Colorado Springs, Colo., as illustrated in
Typically, different catheter diameter sizes are manufactured to accommodate the different size blood vessels found in the human body. For instance, catheters may be manufactured in different vessel sizes ranging between 0.9 mm diameter and 2.5 mm diameter. Catheters on the larger end of this range have been used to clean larger vessels more effectively than smaller catheters. Such is the case because the larger tip on a large catheter has a larger diameter from which laser energy may be emitted to contact plaque on the vessel wall. However, conventional catheters typically have tips that are equivalent in diameter to the catheter shaft. Such a configuration has proven problematic because the entry hole must be as large as the site in the vessel from which plaque is to be removed. This is problematic because the necessity for a larger entry hole creates more potential for vessel trauma and related complications. In addition, in small female patients, a catheter that is large enough to complete the surgery often times will simply not fit through vessel at the entry point (the access site).
An alternative catheter was invented in an attempt to overcome these problems. The alternative catheter, as shown in
This invention is directed to a laser catheter with an operationally adjustable laser target zone. The laser catheter may include one or more optical fibers at a tip of the catheter. The laser catheter may be constructed such that the operational laser target zone is variable, thereby enabling the catheter to be inserted into a vessel of a patient where the tip may be enlarged during the process to effectively remove plaque causing arterial blockages by positioning laser emitting optical fibers closer to the walls of the vessel in a patient. The variability of the operational laser target zone enables plaque to be ablated from a vessel more efficiently and in less time than conventional systems.
In another embodiment, the laser catheter may be constructed such that the operational laser target zone is variable and amenable to gradual increments in target ablation. The catheter may also be configured such that directional increments in a target zone can be achieved, thereby enabling the catheter to be inserted into a vessel of a patient such that the tip may be shifted from a central location in a vessel lumen by inflating the eccentrically placed balloon on the side of the tip of the catheter. Such a system enables directional ablation in the areas of eccentric plaque build up. The laser catheter also facilitates more effective removal of plaque causing arterial blockages by positioning laser emitting optical fibers closer to the walls of the vessel in a patient. The variability of the operational laser target zone enables plaque to be ablated from a vessel more efficiently and in less time than conventional systems. The variability of the operational laser target zone also enables the laser energy to be directed where it is most needed in the vessels with eccentric plaques. The eccentrically positioned balloon enables a single catheter to be used to treat multiple sized vessels without the need to use multiple sized catheters.
In one embodiment, the laser catheter may include with an operationally adjustable laser target zone formed from an inner lumen formed by at least one hollow wire and a compliant balloon positioned at least proximate to a tip of the inner lumen such that the compliant balloon is positioned radially outward from the inner lumen. The laser catheter may also include a compliant material jacket positioned radially outward from the compliant balloon that forms an outer housing for the laser catheter at least at the tip and a plurality of optical fibers positioned in the compliant material jacket radially outward from the compliant balloon. The optical fibers may be configured to be placed in communication with at least one laser generator and extend to the tip. The optical fibers terminate at an end of the laser catheter. The laser catheter may also include a distal flush lumen that terminates at a distal end of the laser catheter. The distal flush lumen is eccentrically positioned.
In another embodiment, the laser catheter may include a compliant balloon positioned at least proximate to a tip of the inner lumen such that the compliant balloon is positioned radially outward from the inner lumen and is positioned eccentrically relative to the inner lumen. The eccentric balloon may be attached to an outer surface of the inner lumen and may extend radially outward therefrom. Alternatively, the eccentric balloon may be attached to the inner lumen and extends radially inward therefrom. A distal flush lumen may be included and may terminate at a distal end of the laser catheter, The distal flush lumen may be eccentrically positioned.
An advantage of this invention is that the laser catheter has the ability to change the distal catheter tip diameter after introducing the catheter into the vessel while maintaining a relatively small catheter shaft and thus a small vascular entry point and while maintaining the same centric ablative path. In embodiments in which there is an eccentrically positioned balloon, the orientation of the optical fibers within the tip may be changed. Such orientation will allow an operator physician to define and adjust the desired degree of eccentricity for each particular plaque allowing for example a two millimeter laser catheter to be used to ablate eccentric plaque in vessels as big as 3-8 mm in diameter or larger depending on the inflated diameter used. Such configuration significantly enhances the safety of the device and improves the cost effectiveness by enabling a physician to use one catheter to treat more than one vessel size in one operative session.
Another advantage of this invention is that use of the laser catheter enables one to maintain a relatively small access point sheath size, such as about less than 7 French, whereby each French size is equal to 0.33 mm.
Yet another advantage of this invention is that the laser catheter improves the ease of use of the device.
Another advantage of the laser catheter is that with balloon inflations, the outer surface of the compliant material jacket may touch the vessel wall proximal to the laser ablation site, thereby making the tip more reliable in treating a portion of the vessel at the plaque site such that the site is void of blood and increasing the effectiveness of laser ablation.
Still another advantage of this invention is that the laser catheter may be very useful because of the staggering growth in prevalence of arterial blockages and because of an increasing number of patients with previously implanted stents that have re-occluded due to recurrent plaque.
Another advantage of this invention is that the laser catheter 10 may be very useful because of the staggering growth in prevalence of arterial blockages, and of increasing number of patients with previously implanted stents that have re-occluded due to recurrent plaque.
These and other embodiments are described in more detail below.
The accompanying drawings, which are incorporated in and form a part of the specification, illustrate embodiments of the presently disclosed invention and, together with the description, disclose the principles of the invention.
As shown in
The laser catheter 10 may be formed from a flexible, hollow tube 16, which may be referred to as an inner lumen, as shown in
In another embodiment, the compliant balloon 18 may be positioned eccentrically, as shown in
In yet another embodiment, the laser catheter 10 may include an eccentric wire lumen 30, as shown in
The laser catheter 10 may also include a compliant material jacket 20 positioned radially outward from the compliant balloon 18 as shown in
The laser catheter 10 may include one or more optical fibers 12 positioned in the compliant material jacket 20 that is radially outward from the compliant balloon 18. The optical fibers 12 may be in communication with at least one laser generator (not shown). In at least one embodiment, the laser catheter 10 may include a plurality of optical fibers 12 positioned within the compliant material jacket 20. The optical fibers 12 may extend generally parallel to the inner lumen 16 and may be positioned radially outward from the inner lumen 16. The optical fibers 12 may be positioned circumferentially around the inner lumen 16. The balloon 18 may be positioned centrally within the circular configuration of the inner lumen 16 or eccentrically within the laser catheter 10 such as eccentrically within or immediately radially outside of a catheter sheath. The optical fibers 12 may be spaced equidistant from each other, spaced random distances from each other, positioned in patterns, or positioned otherwise. The optical fibers 12 may terminate at the tip 14 such that laser beams may be emitted from the optical fibers 12 and strike plaque within vessels in a patient. In another embodiment, the optical fibers 12 may be placed around the wire lumen 16 with the distal flush lumen 32 at the tip 14 of the catheter or at a distance from the tip 14.
During use, the catheter 10 of
In the embodiment in which the compliant balloon 18 is positioned eccentrically, as shown in
The foregoing is provided for purposes of illustrating, explaining, and describing embodiments of this invention. Modifications and adaptations to these embodiments will be apparent to those skilled in the art and may be made without departing from the scope or spirit of this invention.
Claims
1. A laser catheter with an operationally adjustable laser target zone, comprising:
- an inner lumen formed by at least one hollow wire;
- a compliant balloon positioned at least proximate to a tip of the inner lumen such that the compliant balloon is positioned radially outward from the inner lumen;
- a compliant material jacket positioned radially outward from the compliant balloon that forms an elongated outer housing for the laser catheter at least at the tip; and
- a plurality of optical fibers positioned in the compliant material jacket radially outward from the compliant balloon, wherein the optical fibers are configured to be placed in communication with at least one laser generator and extend to the tip.
2. The laser catheter of claim 1, wherein the optical fibers terminate at an end of the laser catheter.
3. The laser catheter of claim 1, further comprising a distal flush lumen that terminates at a distal end of the laser catheter.
4. The laser catheter of claim 4, wherein the distal flush lumen is eccentrically positioned.
5. The laser catheter of claim 1, wherein the inner lumen is positioned eccentrically.
6. A laser catheter with an operationally adjustable laser target zone, comprising:
- an inner lumen formed by at least one hollow wire;
- a compliant balloon positioned at least proximate to a tip of the inner lumen such that the compliant balloon is positioned radially outward from the inner lumen and is positioned eccentrically relative to the inner lumen;
- a compliant material jacket positioned radially outward from the compliant balloon that forms an outer housing for the laser catheter at least at the tip; and
- a plurality of optical fibers positioned in the compliant material jacket, wherein the optical fibers are configured to be placed in communication with at least one laser generator and extend to the tip.
7. The laser catheter of claim 6, wherein the eccentric balloon is attached to an outer surface of the inner lumen and extends radially outward therefrom.
8. The laser catheter of claim 6, wherein the eccentric balloon is attached to the inner lumen and extends radially inward therefrom.
9. The laser catheter of claim 6, further comprising a distal flush lumen that terminates at a distal end of the laser catheter.
10. The laser catheter of claim 9, wherein the distal flush lumen is eccentrically positioned.
11. The laser catheter of claim 6, wherein the inner lumen is positioned eccentrically.
Type: Application
Filed: Apr 1, 2009
Publication Date: Oct 8, 2009
Inventors: Yazan Khatib (Jacksonville, FL), Mays Khatib (Jacksonville, FL), Ahmed Khatib (Jacksonville, FL)
Application Number: 12/416,718
International Classification: A61B 18/24 (20060101);